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1.  Selection Criteria for Patients With Chronic Ankle Instability in Controlled Research: A Position Statement of the International Ankle Consortium 
Journal of Athletic Training  2014;49(1):121-127.
ABSTRACT
While research on chronic ankle instability (CAI) and awareness of its impact on society and health care systems has grown substantially in the last 2 decades, the inconsistency in participant or patient selection criteria across studies presents a potential obstacle to addressing the problem properly. This major gap within the literature limits the ability to generalize this evidence to the target patient population. Therefore, there is a need to provide standards for patient or participant selection criteria in research focused on CAI with justifications using the best available evidence. The International Ankle Consortium provides this position paper to present and discuss an endorsed set of selection criteria for patients with CAI based on the best available evidence to be used in future research and study designs. These recommendations will enhance the validity of research conducted in this clinical population with the end goal of bringing the research evidence to the clinician and patient.
doi:10.4085/1062-6050-49.1.14
PMCID: PMC3917288  PMID: 24377963
2.  Interrater Reliability of the Star Excursion Balance Test 
Journal of Athletic Training  2013;48(5):621-626.
Context:
Dynamic postural control has gained popularity as a more useful assessment of function than static postural control. One measurement of dynamic postural control that has increased in frequency of use is the Star Excursion Balance Test (SEBT). Although the intrarater reliability of the SEBT is excellent, few authors have determined interrater reliability. Preliminary evidence has shown poor reliability between assessors.
Objective:
To determine interrater reliability using a group of investigators at 2 testing sites. A corollary purpose was to examine the interrater reliability when using normalized and nonnormalized performance scores on the SEBT.
Design:
Descriptive laboratory study.
Setting:
University research laboratory.
Patients or Other Participants:
A total of 29 healthy participants between 18 and 50 years of age.
Intervention(s):
Participants were evaluated by 5 raters at 2 testing sites. After participants performed 4 practice trials, each rater assessed 3 test trials in the anterior, posteromedial, and posterolateral reaching directions of the SEBT.
Main Outcome Measure(s):
Normalized and nonnormalized (leg-length) reaching distances were analyzed. Additionally, the mean and maximum values from the 3 test trials were analyzed, producing a total of 16 variables.
Results:
For all 16 measures, the interrater reliability was excellent. For the normalized maximum excursion distances, the intraclass correlation coefficients (1,1) ranged from 0.86 to 0.92. Reliability for the nonnormalized measurements was stronger, ranging from 0.89 to 0.94.
Conclusions:
When the raters have been trained by an experienced rater, the SEBT is a test with excellent reliability when used across multiple raters in different settings. This information adds to the body of knowledge that exists regarding the usefulness of the SEBT as an assessment tool in clinical and research practice. Establishing excellent interrater reliability with normalized and nonnormalized scores strengthens the evidence for using the SEBT, especially at multiple sites.
doi:10.4085/1062-6050-48.3.03
PMCID: PMC3784363  PMID: 24067151
dynamic postural control; clinical balance tests; functional balance
3.  Pain education to prevent chronic low back pain: a study protocol for a randomised controlled trial 
BMJ Open  2014;4(6):e005505.
Introduction
Low back pain (LBP) is the leading cause of disability worldwide. Of those patients who present to primary care with acute LBP, 40% continue to report symptoms 3 months later and develop chronic LBP. Although it is possible to identify these patients early, effective interventions to improve their outcomes are not available. This double-blind (participant/outcome assessor) randomised controlled trial will investigate the efficacy of a brief educational approach to prevent chronic LBP in ‘at-risk’ individuals.
Methods/analysis
Participants will be recruited from primary care practices in the Sydney metropolitan area. To be eligible for inclusion participants will be aged 18–75 years, with acute LBP (<4 weeks’ duration) preceded by at least a 1 month pain-free period and at-risk of developing chronic LBP. Potential participants with chronic spinal pain and those with suspected serious spinal pathology will be excluded. Eligible participants who agree to take part will be randomly allocated to receive 2×1 h sessions of pain biology education or 2×1 h sessions of sham education from a specially trained study physiotherapist. The study requires 101 participants per group to detect a 1-point difference in pain intensity 3 months after pain onset. Secondary outcomes include the incidence of chronic LBP, disability, pain intensity, depression, healthcare utilisation, pain attitudes and beliefs, global recovery and recurrence and are measured at 1 week post-intervention, and at 3, 6 and 12 months post LBP onset.
Ethics/dissemination
Ethical approval was obtained from the University of New South Wales Human Ethics Committee in June 2013 (ref number HC12664). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.
Trial registration number
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808
doi:10.1136/bmjopen-2014-005505
PMCID: PMC4054624  PMID: 24889854
Pain Management; Preventive Medicine; Primary Care
4.  Design and Reliability of a Novel Heel Rise Test Measuring Device for Plantarflexion Endurance 
BioMed Research International  2014;2014:391646.
Background. Plantarflexion results from the combined action of the soleus and gastrocnemius muscles in the calf. The heel rise test is commonly used to test calf muscle endurance, function, and performance by a wide variety of professionals; however, no uniform description of the test is available. This paper aims to document the construction and reliability of a novel heel rise test device and measurement protocol that is suitable for the needs of most individuals. Methods. This device was constructed from compact and lightweight materials and is fully adjustable, enabling the testing of a wide variety of individuals. It is easy to assemble and disassemble, ensuring that it is portable for use in different settings. Findings. We tested reliability on 40 participants, finding excellent interrater reliability (ICC2,1 0.97, 95% CI: 0.94 to 0.98). Limits of agreement were less than two repetitions in 90% of cases and the Bland-Altman plot showed no bias. Interpretation. We have designed a novel, standardized, simple, and reliable device and measurement protocol for the heel rise test which can be used by researchers and clinicians in a variety of settings.
doi:10.1155/2014/391646
PMCID: PMC4022004  PMID: 24877089
5.  A qualitative study of influences on older women’s practitioner choices for back pain care 
Background
Back pain is an increasingly prevalent health concern amongst Australian women for which a wide range of treatment options are available, offered by biomedical, allied health and complementary and alternative medicine (CAM) providers. Although there is an emerging literature on patterns of provider utilisation, less is known about the reasons why women with back pain select their chosen practitioner. In this paper we explore the influences on back pain sufferers’ decision-making about treatment seeking with practitioners for their most recent episode of back pain.
Methods
Drawing on 50 semi-structured interviews with women aged 60–65 years from the Australian Longitudinal Study on Women’s Health (ALSWH) who have chronic back pain, we focus on the factors which influence their choice of practitioner. Analysis followed a framework approach to qualitative content analysis, augmented by NVivo 9 qualitative data analysis software. Key themes were identified and tested for rigour through inter-rater reliability and constant comparison.
Results
The women identified four predominant influences on their choice of practitioner for back pain: familiarity with treatment or experiences with individual practitioners; recommendations from social networks; geographical proximity of practitioners; and, qualifications and credentials of practitioners. The therapeutic approach or evidence-base of the practices being utilised was not reported by the women as central to their back pain treatment decision making.
Conclusions
Choice of practitioner appears to be unrelated to the therapeutic approaches, treatment practices or the scientific basis of therapeutic practices. Moreover, anecdotal lay reports of effectiveness and the ‘treatment experience’ may be more influential than formal qualifications in guiding women’s choice of practitioner for their back pain. Further work is needed on the interpersonal, collective and subjective underpinnings of practitioner choice, particularly over time, in order to better understand why women utilise certain practitioners for back pain.
doi:10.1186/1472-6963-14-131
PMCID: PMC3998023  PMID: 24655816
Back pain; Women; Qualitative; Interviews; Australia
6.  Does progressive resistance and balance exercise reduce falls in residential aged care? Randomized controlled trial protocol for the SUNBEAM program 
Introduction
Falls are common among older adults. It is reported that approximately 60% of residents of aged care facilities fall each year. This is a major cause of morbidity and mortality, and a significant burden for health care providers and the health system. Among community dwelling older adults, exercise appears to be an effective countermeasure, but data are limited and inconsistent among studies in residents of aged care communities. This trial has been designed to evaluate whether the SUNBEAM program (Strength and Balance Exercise in Aged Care) reduces falls in residents of aged care facilities.
Research question
Is the program more effective and cost-effective than usual care for the prevention of falls?
Design
Single-blinded, two group, cluster randomized trial.
Participants and setting
300 residents, living in 20 aged care facilities.
Intervention
Progressive resistance and balance training under the guidance of a physiotherapist for 6 months, then facility-guided maintenance training for 6 months.
Control
Usual care.
Measurements
Number of falls, number of fallers, quality of life, mobility, balance, fear of falling, cognitive well-being, resource use, and cost-effectiveness. Measurements will be taken at baseline, 6 months, and 12 months.
Analysis
The number of falls will be analyzed using a Poisson mixed model. A logistic mixed model will be used to analyze the number of residents who fall during the study period. Intention-to-treat analysis will be used.
Discussion
This study addresses a significant shortcoming in aged care research, and has potential to impact upon a substantial health care problem. Outcomes will be used to inform care providers, and guide health care policies.
doi:10.2147/CIA.S53931
PMCID: PMC3937111  PMID: 24591821
balance; strength; training; falls; nursing care; cost-effectiveness
7.  Health Care Utilisation and Out-of-Pocket Expenditure Associated with Back Pain: A Nationally Representative Survey of Australian Women 
PLoS ONE  2013;8(12):e83559.
Background
Back pain impacts on a significant proportion of the Australian population over the life course and has high prevalence rates among women, particularly in older age. Back pain care is characterised by multiple practitioner and self-prescribed treatment options, and the out-of-pocket costs associated with consultations and self-prescribed treatments have not been examined to date.
Objective
To analyse the extent of health care practitioner consultations and self-prescribed treatment for back pain care among Australian women, and to assess the self-reported costs associated with such usage.
Methods
Survey of 1,310 women (response rate 80.9%) who reported seeking help for back pain from the ‘1946-51 cohort’ of the Australian Longitudinal Study on Women’s Health. Women were asked about their use of health care practitioners and self-prescribed treatments for back pain and the costs associated with such usage.
Results
In the past year 76.4% consulted a complementary and alternative practitioner, 56% an allied health practitioner and 59.2% a GP/medical specialist. Overall, women consulted with, on average, 3.0 (SD = 2.0) different health care practitioners, and had, on average, 12.2 (SD = 9.7) discrete health care practitioner consultations for back pain. Average self-reported out-of-pocket expenditure on practitioners and self-prescribed treatments for back pain care per annum was AU$873.10.
Conclusions
Multiple provider usage for various but distinct purposes (i.e. pain/mobility versus anxiety/stress) points to the need for further research into patient motivations and experiences of back pain care in order to improve and enhance access to and continuity of care. Our results suggest that the cost of back pain care represents a significant burden, and may ultimately limit women’s access to multiple providers. We extrapolate that for Australian working-age women, total out-of-pocket expenditure on back pain care per annum is in excess of AU$1.4billion, thus indicating the prominence of back pain as a major economic, social and health burden.
doi:10.1371/journal.pone.0083559
PMCID: PMC3869794  PMID: 24376716
8.  Use of complementary and alternative medicine by mid-age women with back pain: a national cross-sectional survey 
Background
The use of complementary and alternative medicine (CAM) has increased significantly in Australia over the past decade. Back pain represents a common context for CAM use, with increasing utilisation of a wide range of therapies provided within and outside conventional medical facilities. We examine the relationship between back pain and use of CAM and conventional medicine in a national cohort of mid-aged Australian women.
Methods
Data is taken from a cross-sectional survey (n = 10492) of the mid-aged cohort of the Australian Longitudinal Study on Women’s Health, surveyed in 2007. The main outcome measures were: incidence of back pain the previous 12 months, and frequency of use of conventional or CAM treatments in the previous 12 months.
Results
Back pain was experienced by 77% (n = 8063) of the cohort in the previous twelve month period. The majority of women with back pain only consulted with a conventional care provider (51.3%), 44.2% of women with back pain consulted with both a conventional care provider and a CAM practitioner. Women with more frequent back pain were more likely to consult a CAM practitioner, as well as seek conventional care. The most commonly utilised CAM practitioners were massage therapy (26.5% of those with back pain) and chiropractic (16.1% of those with back pain). Only 1.7% of women with back pain consulted with a CAM practitioner exclusively.
Conclusions
Mid-aged women with back pain utilise a range of conventional and CAM treatments. Consultation with CAM practitioners or self-prescribed CAM was predominantly in addition to, rather than a replacement for, conventional care. It is important that health professionals are aware of potential multiple practitioner usage in the context of back pain and are prepared to discuss such behaviours and practices with their patients.
doi:10.1186/1472-6882-12-98
PMCID: PMC3493383  PMID: 22809262
Back pain; Complementary medicine; Survey
9.  Assessment of chronic ankle instability 
doi:10.1186/1757-1146-5-S1-I2
PMCID: PMC3323472
10.  Chronic Ankle Instability: Evolution of the Model 
Journal of Athletic Training  2011;46(2):133-141.
Abstract
Context:
The Hertel model of chronic ankle instability (CAI) is commonly used in research but may not be sufficiently comprehensive. Mechanical instability and functional instability are considered part of a continuum, and recurrent sprain occurs when both conditions are present. A modification of the Hertel model is proposed whereby these 3 components can exist independently or in combination.
Objective:
To examine the fit of data from people with CAI to 2 CAI models and to explore whether the different subgroups display impairments when compared with a control group.
Design:
Cross-sectional study.
Patients or Other Participants:
Community-dwelling adults and adolescent dancers were recruited: 137 ankles with ankle sprain for objective 1 and 81 with CAI and 43 controls for objective 2.
Intervention(s):
Two balance tasks and time to recover from an inversion perturbation were assessed to determine if the subgroups demonstrated impairments when compared with a control group (objective 2).
Main Outcome Measure(s):
For objective 1 (fit to the 2 models), outcomes were Cumberland Ankle Instability Tool score, anterior drawer test results, and number of sprains. For objective 2, outcomes were 2 balance tasks (number of foot lifts in 30 seconds, ability to balance on the ball of the foot) and time to recover from an inversion perturbation. The Cohen d was calculated to compare each subgroup with the control group.
Results:
A total of 56.5% of ankles (n = 61) fit the Hertel model, whereas all ankles (n = 108) fit the proposed model. In the proposed model, 42.6% of ankles were classified as perceived instability, 30.5% as recurrent sprain and perceived instability, and 26.9% as among the remaining groups. All CAI subgroups performed more poorly on the balance and inversion-perturbation tasks than the control group. Subgroups with perceived instability had greater impairment in single-leg stance, whereas participants with recurrent sprain performed more poorly than the other subgroups when balancing on the ball of the foot. Only individuals with hypomobility appeared unimpaired when recovering from an inversion perturbation.
Conclusions:
The new model of CAI is supported by the available data. Perceived instability alone and in combination characterized the majority of participants. Several impairments distinguished the sprain groups from the control group.
doi:10.4085/1062-6050-46.2.133
PMCID: PMC3070500  PMID: 21391798
ankle injuries; joint instability; postural balance; recurrent ankle sprains
11.  Prognosis for patients with chronic low back pain: inception cohort study 
Objectives To describe the course of chronic low back pain in an inception cohort and to identify prognostic markers at the onset of chronicity.
Design Inception cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants The study sample was a subcohort of an inception cohort of 973 consecutive patients presenting to primary care with acute low back pain (<2 weeks’ duration). 406 participants whose pain persisted for three months formed the inception cohort of patients with chronic low back pain.
Main outcome measures Outcomes and putative predictors measured at initial presentation, onset of chronicity (study entry), and follow-up at nine and 12 months. Recovery was determined from measures of pain intensity, disability, and work status. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results Completeness of follow-up was 97% of total person time for all outcomes. The cumulative probability of being pain-free was 35% at nine months and 42% at 12 months and for complete recovery was 35% at nine months and 41% at 12 months. Of the 259 participants who had not recovered from pain related disability at entry to the chronic study, 47% had recovered by 12 months. Previous sick leave due to low back pain, high disability levels or high pain intensity at onset of chronicity, low levels of education, greater perceived risk of persistent pain, and being born outside Australia were associated with delayed recovery.
Conclusion More than one third of patients with recent onset, non-radicular chronic low back pain recover within 12 months. The prognosis is less favourable for those who have taken previous sick leave for low back pain, have high disability levels or high pain intensity at onset of chronic low back pain, have lower education, perceive themselves as having a high risk of persistent pain, and were born outside Australia.
doi:10.1136/bmj.b3829
PMCID: PMC2758336  PMID: 19808766
12.  Screening for malignancy in low back pain patients: a systematic review 
European Spine Journal  2007;16(10):1673-1679.
To describe the accuracy of clinical features and tests used to screen for malignancy in patients with low back pain. A systematic review was performed on all available records on MEDLINE, EMBASE, and CINAHL electronic databases. Studies were considered eligible if they investigated a cohort of low back pain patients, used an appropriate reference standard, and reported sufficient data on the diagnostic accuracy of tests. Two authors independently assessed methodological quality and extracted data to calculate positive (LR+) and negative (LR−) likelihood ratios. Six studies evaluating 22 different clinical features and tests were identified. The prevalence of malignancy ranged from 0.1 to 3.5%. A previous history of cancer (LR+ = 23.7), elevated ESR (LR+ = 18.0), reduced hematocrit (LR+ = 18.2), and overall clinician judgement (LR+ = 12.1) increased the probability of malignancy when present. A combination of age ≥50 years, a previous history of cancer, unexplained weight loss, and failure to improve after 1 month had a reported sensitivity of 100%. Overall, there was poor reporting of methodological quality items, and very few studies were performed in community primary care settings. Malignancy is rare as a cause of low back pain. The most useful features and tests are a previous history of cancer, elevated ESR, reduced hematocrit, and clinician judgement.
doi:10.1007/s00586-007-0412-0
PMCID: PMC2078307  PMID: 17566791
Low back pain; Diagnosis; Malignancy; Red flags
13.  Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study 
BMJ : British Medical Journal  2008;337(7662):154-157.
Objective To estimate the one year prognosis and identify prognostic factors in cases of recent onset low back pain managed in primary care.
Design Cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants An inception cohort of 973 consecutive primary care patients (mean age 43.3, 54.8% men) with non-specific low back pain of less than two weeks’ duration recruited from the clinics of 170 general practitioners, physiotherapists, and chiropractors.
Main outcome measures Participants completed a baseline questionnaire and were contacted six weeks, three months, and 12 months after the initial consultation. Recovery was assessed in terms of return to work, return to function, and resolution of pain. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results The follow-up rate over the 12 months was more than 97%. Half of those who reduced their work status at baseline had returned to previous work status within 14 days (95% confidence interval 11 to 17 days) and 83% had returned to previous work status by three months. Disability (median recovery time 31 days, 25 to 37 days) and pain (median 58 days, 52 to 63 days) took much longer to resolve. Only 72% of participants had completely recovered 12 months after the baseline consultation. Older age, compensation cases, higher pain intensity, longer duration of low back pain before consultation, more days of reduced activity because of lower back pain before consultation, feelings of depression, and a perceived risk of persistence were each associated with a longer time to recovery.
Conclusions In this cohort of patients with acute low back pain in primary care, prognosis was not as favourable as claimed in clinical practice guidelines. Recovery was slow for most patients. Nearly a third of patients did not recover from the presenting episode within a year.
doi:10.1136/bmj.a171
PMCID: PMC2483884  PMID: 18614473
14.  Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study 
Objective To estimate the one year prognosis and identify prognostic factors in cases of recent onset low back pain managed in primary care.
Design Cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants An inception cohort of 973 consecutive primary care patients (mean age 43.3, 54.8% men) with non-specific low back pain of less than two weeks’ duration recruited from the clinics of 170 general practitioners, physiotherapists, and chiropractors.
Main outcome measures Participants completed a baseline questionnaire and were contacted six weeks, three months, and 12 months after the initial consultation. Recovery was assessed in terms of return to work, return to function, and resolution of pain. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results The follow-up rate over the 12 months was more than 97%. Half of those who reduced their work status at baseline had returned to previous work status within 14 days (95% confidence interval 11 to 17 days) and 83% had returned to previous work status by three months. Disability (median recovery time 31 days, 25 to 37 days) and pain (median 58 days, 52 to 63 days) took much longer to resolve. Only 72% of participants had completely recovered 12 months after the baseline consultation. Older age, compensation cases, higher pain intensity, longer duration of low back pain before consultation, more days of reduced activity because of lower back pain before consultation, feelings of depression, and a perceived risk of persistence were each associated with a longer time to recovery.
Conclusions In this cohort of patients with acute low back pain in primary care, prognosis was not as favourable as claimed in clinical practice guidelines. Recovery was slow for most patients. Nearly a third of patients did not recover from the presenting episode within a year.
doi:10.1136/bmj.a171
PMCID: PMC2483884  PMID: 18614473
15.  Low back pain research priorities: a survey of primary care practitioners 
BMC Family Practice  2007;8:40.
Background
Despite the large amount of time and money which has been devoted to low back pain research, successful management remains an elusive goal and low back pain continues to place a large burden on the primary care setting. One reason for this may be that the priorities for research are often developed by researchers and funding bodies, with little consideration of the needs of primary care practitioners. This study aimed to determine the research priorities of primary care practitioners who manage low back pain on a day-to-day basis.
Methods
A modified-Delphi survey of primary care practitioners was conducted, consisting of three rounds of questionnaires. In the first round, 70 practitioners who treat low back pain were each asked to provide up to five questions which they would like answered with respect to low back pain in primary care. The results were collated into a second round questionnaire consisting of 39 priorities, which were rated for importance by each practitioner on a likert-scale. The third round consisted of asking the practitioners to rank the top ten priorities in order of importance.
Results
Response rates for the modified-Delphi remained above 70% throughout the three rounds. The ten highest ranked priorities included the identification of sub-groups of patients that respond optimally to different treatments, evaluation of different exercise approaches in the management of low back pain, self-management of low back pain, and comparison of different treatment approaches by primary care professions treating low back pain.
Conclusion
Practitioners identified a need for more information on a variety of topics, including diagnosis, the effectiveness of treatments, and identification of patient characteristics which affect treatment and recovery.
doi:10.1186/1471-2296-8-40
PMCID: PMC1955444  PMID: 17625004
16.  The development of an arm activity survey for breast cancer survivors using the Protection Motivation Theory 
BMC Cancer  2007;7:75.
Background
Current research evidence indicates that women should return to normal use of their arm after breast cancer surgery. However, it appears some women continue to hold the view that they are supposed to protect their arm from strenuous activities because of the risk of lymphoedema. Many factors contribute to women's perceptions about lymphoedema and their ability to use their affected arm, and it is the aim of this study to explore and understand these perceptions.
Methods/design
A survey, based on the Protection Motivation Theory, has been developed and tested. The survey assesses whether subjective norms, fear and/or coping attributes predict women's intention to use their affected arm. In addition, the survey includes questions regarding cancer treatment and demographic characteristics, arm and chest symptoms, and arm function. Recruitment of 170 breast cancer survivors has begun at 3 cancer treatment sites in Sydney, Australia.
Discussion
This study will identify perceptions that help predict the extent women use their affected arm. The results will also determine whether upper limb impairments arise secondary to over-protection of the affected arm. Identification of factors that limit arm use will enable appropriate prevention and better provision of treatment to improve upper limb outcomes.
doi:10.1186/1471-2407-7-75
PMCID: PMC1876466  PMID: 17488497
17.  Efficacy of manipulation for non-specific neck pain of recent onset: design of a randomised controlled trial 
Background
Manipulation is a common treatment for non-specific neck pain. Neck manipulation, unlike gentler forms of manual therapy such as mobilisation, is associated with a small risk of serious neurovascular injury and can result in stroke or death. It is thought however, that neck manipulation provides better results than mobilisation where clinically indicated. There is long standing and vigorous debate both within and between the professions that use neck manipulation as well as the wider scientific community as to whether neck manipulation potentially does more harm than good. The primary aim of this study is to determine whether neck manipulation provides more rapid resolution of an episode of neck pain than mobilisation.
Methods/Design
182 participants with acute and sub-acute neck pain will be recruited from physiotherapy, chiropractic and osteopathy practices in Sydney, Australia. Participants will be randomly allocated to treatment with either manipulation or mobilisation. Randomisation will occur after the treating practitioner decides that manipulation is an appropriate treatment for the individual participant. Both groups will receive at least 4 treatments over 2 weeks. The primary outcome is number of days taken to recover from the episode of neck pain. Cox regression will be used to compare survival curves for time to recovery for the manipulation and mobilisation treatment groups.
Discussion
This paper presents the rationale and design of a randomised controlled trial to compare the effectiveness of neck manipulation and neck mobilisation for acute and subacute neck pain.
doi:10.1186/1471-2474-8-18
PMCID: PMC1810535  PMID: 17324291
18.  Prognosis of chronic low back pain: design of an inception cohort study 
Background
Although clinical guidelines generally portray chronic low back pain as a condition with a poor prognosis this portrayal is based on studies of potentially unrepresentative survival cohorts. The aim of this study is to describe the prognosis of an inception cohort of people with chronic low back pain presenting for primary care.
Methods/Design
The study will be an inception cohort study with one year follow-up. Participants are drawn from a cohort of consecutive patients presenting with acute low back pain (less than 2 weeks duration) to primary care clinics in Sydney, Australia. Those patients who continue to experience pain at three months, and are therefore classified as having chronic back pain, are invited to participate in the current study. The cohort will be followed up by telephone at baseline, 9 months and 12 months after being diagnosed with chronic low back pain. Recovery from low back pain will be measured by sampling three different outcomes: pain intensity, interference with function due to pain, and work status. Life tables will be generated to determine the one year prognosis of chronic low back pain. Prognostic factors will be assessed using Cox regression.
Discussion
This study will determine the prognosis of chronic non-specific low back pain in a representative cohort of patients sourced from primary care. The results of this study will improve understanding of chronic low back pain, allowing clinicians to provide more accurate prognostic information to their patients.
doi:10.1186/1471-2474-8-11
PMCID: PMC1800846  PMID: 17288586
19.  Progressive resistance training and stretching following surgery for breast cancer: study protocol for a randomised controlled trial 
BMC Cancer  2006;6:273.
Background
Currently 1 in 11 women over the age of 60 in Australia are diagnosed with breast cancer. Following treatment, most breast cancer patients are left with shoulder and arm impairments which can impact significantly on quality of life and interfere substantially with activities of daily living. The primary aim of the proposed study is to determine whether upper limb impairments can be prevented by undertaking an exercise program of prolonged stretching and resistance training, commencing soon after surgery.
Methods/design
We will recruit 180 women who have had surgery for early stage breast cancer to a multicenter single-blind randomized controlled trial. At 4 weeks post surgery, women will be randomly assigned to either an exercise group or a usual care (control) group. Women allocated to the exercise group will perform exercises daily, and will be supervised once a week for 8 weeks. At the end of the 8 weeks, women will be given a home-based training program to continue indefinitely. Women in the usual care group will receive the same care as is now typically provided, i.e. a visit by the physiotherapist and occupational therapist while an inpatient, and receipt of pamphlets. All subjects will be assessed at baseline, 8 weeks, and 6 months later. The primary measure is arm symptoms, derived from a breast cancer specific questionnaire (BR23). In addition, range of motion, strength, swelling, pain and quality of life will be assessed.
Discussion
This study will determine whether exercise commencing soon after surgery can prevent secondary problems associated with treatment of breast cancer, and will thus provide the basis for successful rehabilitation and reduction in ongoing problems and health care use. Additionally, it will identify whether strengthening exercises reduce the incidence of arm swelling.
Trial Registration
The protocol for this study is registered with the Australian Clinical Trials Registry (ACTRN012606000050550).
doi:10.1186/1471-2407-6-273
PMCID: PMC1693923  PMID: 17140447
20.  Risk factors for neck pain in office workers: a prospective study 
Background
Persisting neck pain is common in society. It has been reported that the prevalence of neck pain in office workers is much higher than in the general population. The costs to the worker, employer and society associated with work-related neck pain are known to be considerable and are escalating. The factors that place office workers at greater risk of developing neck pain are not understood. The aim of this study is to investigate the incidence and risk factors of work-related neck pain in Australian office workers.
Methods/design
We will conduct a prospective cohort study. A cohort of office workers without neck pain will be followed over a 12 month period, after baseline measurement of potential risk factors. The categories of risk factors being evaluated are physical (cervical spine posture, range of movement, muscle endurance and exercise frequency), demographic (age, sex), work environment (sitting duration, frequency of breaks) and psychosocial (psychological distress and psychosocial work factors). Cox regression analysis will be used to identify risk factors associated with work-related neck pain, and will be expressed as hazard ratios with 95% confidence intervals. The data will also enable the incidence of neck pain in this population to be estimated.
Discussion
In addition to clarifying the magnitude of this occupational health problem these data could inform policy in workplaces and provide the basis for primary prevention of neck pain in office workers, targeting the identified risk factors.
doi:10.1186/1471-2474-7-81
PMCID: PMC1629016  PMID: 17062165
21.  Reliability of two goniometric methods of measuring active inversion and eversion range of motion at the ankle 
Background
Active inversion and eversion ankle range of motion (ROM) is widely used to evaluate treatment effect, however the error associated with the available measurement protocols is unknown. This study aimed to establish the reliability of goniometry as used in clinical practice.
Methods
30 subjects (60 ankles) with a wide variety of ankle conditions participated in this study. Three observers, with different skill levels, measured active inversion and eversion ankle ROM three times on each of two days. Measurements were performed with subjects positioned (a) sitting and (b) prone. Intra-class correlation coefficients (ICC[2,1]) were calculated to determine intra- and inter-observer reliability.
Results
Within session intra-observer reliability ranged from ICC[2,1] 0.82 to 0.96 and between session intra-observer reliability ranged from ICC[2,1] 0.42 to 0.80. Reliability was similar for the sitting and the prone positions, however, between sessions, inversion measurements were more reliable than eversion measurements. Within session inter-observer measurements in sitting were more reliable than in prone and inversion measurements were more reliable than eversion measurements.
Conclusion
Our findings show that ankle inversion and eversion ROM can be measured with high to very high reliability by the same observer within sessions and with low to moderate reliability by different observers within a session. The reliability of measures made by the same observer between sessions varies depending on the direction, being low to moderate for eversion measurements and moderate to high for inversion measurements in both positions.
doi:10.1186/1471-2474-7-60
PMCID: PMC1550229  PMID: 16872545
22.  Prognosis of acute low back pain: design of a prospective inception cohort study 
Background
Clinical guidelines generally portray acute low back pain as a benign and self-limiting condition. However, evidence about the clinical course of acute low back pain is contradictory and the risk of subsequently developing chronic low back pain remains uncertain. There are few high quality prognosis studies and none that have measured pain, disability and return to work over a 12 month period. This study aims to provide the first estimates of the one year prognosis of acute low back pain (pain of less than 2 weeks duration) in patients consulting primary care practitioners. A secondary aim is to identify factors that are associated with the prognosis of low back pain.
Methods/Design
The study is a prospective inception cohort study. Consecutive patients consulting general medical practitioners, physiotherapists and chiropractors in the Sydney metropolitan region will complete a baseline questionnaire regarding their back pain. Subsequently these patients will be followed up by telephone 6 weeks, 3 months and 12 months after the initial consultation. Patients will be considered to have recovered from the episode of back pain if they have no pain and no limitation of activity, and have returned to pre-injury work status. Life tables will be generated to determine the one year prognosis of acute low back pain. Prognostic factors will be assessed using Cox regression.
Discussion
This study will provide the first estimates of the one year prognosis of acute low back pain in a representative sample of primary care patients.
doi:10.1186/1471-2474-7-54
PMCID: PMC1543628  PMID: 16790069
23.  Effectiveness of joint mobilisation after cast immobilisation for ankle fracture: a protocol for a randomised controlled trial [ACTRN012605000143628] 
Background
Passive joint mobilisation is a technique frequently used by physiotherapists to reduce pain, improve joint movement and facilitate a return to activities after injury, but its use after ankle fracture is currently based on limited evidence. The primary aim of this trial is to determine if adding joint mobilisation to a standard exercise programme is effective and cost-effective after cast immobilisation for ankle fracture in adults.
Methods/Design
Ninety participants will be recruited from the physiotherapy departments of three teaching hospitals and randomly allocated to treatment or control groups using a concealed procedure. All participants will perform an exercise programme. Participants in the treatment group will also receive joint mobilisation twice a week for four weeks. Blinded follow-up assessments will be conducted four, 12 and 24 weeks after randomisation. The primary outcome measures will be the Lower Extremity Functional Scale and the Assessment of Quality of Life. Secondary outcomes will include measures of impairments, activity limitation and participation. Data on the use of physiotherapy services and participants' out-of-pocket costs will be collected for the cost-effective and cost-utility analyses. To test the effects of treatment, between-group differences will be examined with analysis of covariance using a regression approach. The primary conclusions will be based on the four-week follow-up data.
Discussion
This trial incorporates features known to minimise bias. It uses a pragmatic design to reflect clinical practice and maximise generalisability. Results from this trial will contribute to an evidence-based approach for rehabilitation after ankle fracture.
doi:10.1186/1471-2474-7-46
PMCID: PMC1538591  PMID: 16729880
24.  The effect of motor control exercise versus placebo in patients with chronic low back pain [ACTRN012605000262606] 
Background
While one in ten Australians suffer from chronic low back pain this condition remains extremely difficult to treat. Many contemporary treatments are of unknown value. One potentially useful therapy is the use of motor control exercise. This therapy has a biologically plausible effect, is readily available in primary care and it is of modest cost. However, to date, the efficacy of motor control exercise has not been established.
Methods
This paper describes the protocol for a clinical trial comparing the effects of motor control exercise versus placebo in the treatment of chronic non-specific low back pain. One hundred and fifty-four participants will be randomly allocated to receive an 8-week program of motor control exercise or placebo (detuned short wave and detuned ultrasound). Measures of outcomes will be obtained at follow-up appointments at 2, 6 and 12 months after randomisation. The primary outcomes are: pain, global perceived effect and patient-generated measure of disability at 2 months and recurrence at 12 months.
Discussion
This trial will be the first placebo-controlled trial of motor control exercise. The results will inform best practice for treating chronic low back pain and prevent its occurrence.
doi:10.1186/1471-2474-6-54
PMCID: PMC1291370  PMID: 16271149
25.  Advice or exercise for chronic whiplash disorders? Design of a randomized controlled trial 
Background
Whiplash-associated disorder (or "whiplash") is a common condition incurring considerable expense in social and economic terms. A lack of research on effective therapy for patients with chronic whiplash associated disorders prompted the design of the current study. The primary aim of this randomised controlled trial is to determine the effects of a physical activity program for people with chronic (symptoms of > 3 months duration) whiplash. A secondary aim is to determine if pain severity, level of disability and fear of movement/(re)injury predict response to a physical activity program.
Methods / Design
This paper presents the rationale and design of a randomised controlled trial examining the effects of advice and individualized sub-maximal exercise programs in the treatment of whiplash associated disorders.
Discussion
This paper highlights the design, methods and operational aspects of a significant clinical trial in the area of whiplash and chronic pain.
doi:10.1186/1471-2474-4-18
PMCID: PMC194710  PMID: 12932301
Whiplash; Exercise; Advice; Therapy; Neck Pain; Disability.

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